Human Factors Validation (Summative) Study – Our staff can provide an independent,
comprehensive review of the safety and effectiveness of the use of your device to include with
your submission.We can plan,
execute, and document an FDA-compliant simulated-use study. Tasks included in
the study protocol will be based on an assessment of device use-related hazards and primary operating functions.Study participants will be recruited
based on characteristics of identified user groups and results will include
the number of occurrences and root cause analysis of the observed use errors
and near misses.

Formative Evaluations – Whether you are developing an entirely
new interface or adding a feature to an existing interface, our staff can
work with you to determine if one or more formative evaluations are needed
and what areas of the user interface should be targeted.Formative evaluations can range from
quick and informal to “pre-validation like” and provide design guidance on
anywhere from a single feature to the overall user interface.

Usability Risk Analysis assessment and review – From the perspective of the FDA and the
new IEC 62366-1, a summative usability study must
demonstrate safe and effective use of the device. Do you understand what use
errors could result and have you effectively mitigated those errors?Have you identified the areas of the
user interface where the user is required to take action to manage the risk
of certain hazards (and if they can/will do so effectively)?Our staff can assist you with
answering these questions.

The ultimate value of usability
engineering happens when it is related to the overall picture of risk
management for the device, and this is the regulatory expectation - the
described structure of the standards -ISO 14971 and IEC 62366 make this
clear.Our extensive risk
analysis experience with many kinds of devices helps us analyze, understand,
and describe how the usability aspects of your device demonstrate effective
safety risk management.We can
link and integrate usability information with system risk analysis, no matter
what methodology may have been used.

User-Centered Design Tools and Processes – From performing contextual inquires, user
needs analysis, usability risk analysis, individual interviews, focus groups,
functional and task analyzes, heuristic and expert reviews, as well as
formative and summative studies, our staff has the tool set to assist you in
development of a highly usable product that effectively manages safety risk
while offering the features demanded by the market.

Submission Support - An HFE/UE report is needed for your FDA
submission.Our staff can assist
you in streamlining the usability engineering process and providing the
necessary documentation to satisfy both.

Process documents – We can help you create the necessary
plans and standard operating procedures that are essential for IEC 62366
compliance.

Are you facing Notified Body assessment audit
issues related to 60601-1, 3rd Edition because of the lack of
usability documentation? We can help with
retrospective evaluation and efficient approaches to compliance for legacy
products.